*******************************************************************************************************************************************MANUSCRIPT: Authorized Generic Entry prior to Patent Expiry: Reassessing Incentives for Independent Generic Entry *AUTHOR:     Silvia Appelt, University of Munich, silvia.appelt@lrz.uni-muenchen.de******************************************************************************************************************************************					 					                   *** Master dofile ***											          * Date last edit:  11 January 2015 * ******************************************************************************************************************************************                                                                                                        *PROGRAMME: STATA MP 13.0 *OPERATING SYSTEM: Windows Server 2008 R2 Enterprise*DATA SOURCES*** (1) Insight Health NPI database: national pharmaceutical market data, Germany 1999-2007 [NPI DB 2005/2006/2007 covers 1999-2005/2003-2006/2004-2007]** NPI DB 2005/2006/2007 - relevant SQL tables:*pzn: numeric ID (pzn_id) and pharmaceutical retail form (pzn) record: pzn_id x product name x dosage size x package size *hafo: numeric ID (pzn_id) and name of pharmaceutical retail form: product name x dosage size x package size  *act1: numeric ID and name of therapeutic field of indication (ATC1 classification) *act2: numeric ID and name of therapeutic field of indication (ATC2 classification) *act3: numeric ID and name of therapeutic field of indication (ATC2 classification) *atc4: numeric ID and name of therapeutic field of indication (ATC3 classification) *nfc1: numeric ID and name of drug form (NFC1 classification) *nfc2: numeric ID and name of drug form (NFC2 classification) *nfc3: numeric ID and name of drug form (NFC3 classification) *zklass: field of medicine (incl. numeric ID): human medicines, diagnostics, etc.*hst: numeric ID and name of manufacturer(s) of pharmaceutical retail form (pzn)*hst_hist: numeric ID and name of previous manufacturer(s) of pharmaceutical retail form (pzn)  *prd: numeric ID and name of pharmecutical product  *prdo: numeric ID and name of pharmecutical product (parallel imports)  *gen: drug type classification (incl. numeric ID) of pharmaceutical retail form (pzn): on-patent, off-patent original, generic, no generic situation *fbetrag: reference price status (incl. numeric ID) of pharmaceutical retail form (pzn), if applicable*sub: numeric ID and name of active ingredient/substance contained in pharmaceutical retail form (pzn)*str: dosage size (incl. numeric ID) of pharmaceutical retail form (pzn)*pck: package size (incl. numeric ID) of pharmaceutical retail form (pzn)*nnn: package category (incl. numeric ID) of pharmaceutical retail form (pzn): n1, n2, n3*abg: prescription status (incl. numeric ID) of pharmaceutical retail form (pzn)*zzb: copayment status (incl. numeric ID) of pharmaceutical retail form (pzn)*konz: numeric ID and name of parent firm of manufacturer of pharmaceutical retail form (pzn)*einf: date of market launch of pharmaceutical retail form (pzn) and product*val: ex-factory and retail prices and turnover - pharmaceutical retail form (pzn) level (see dofile6_npi_human1_2)*val_hist: market shares of previous producers - pharmaceutical retail form (pzn) level (see dofile6_npi_human1_2)*Unit of observation (NPI DB 2005/2006/2007): pzn (pzn_id) - data includes price/sales information for current producer (val)*Unit of observation (NPI DB 2005/2006/2007): pzn (pzn_id) hist_hist_id - data includes price/sales information for current and previous producers of the retail form (val_hist)*Extract NPI data from SQL database*do dofile_npi_extract_tables_db05*do dofile_npi_extract_tables_db06*do dofile_npi_extract_tables_db07*** (2) Insight Health Patent database: patent and supplementary protection certificate (SPC) data (database 2007)** PATENT/SPC CSV tables:*patent: patentholder, originator, patent appl number, patent appl, date priority numbers, patent classification (among other variables)  *spc: spc applicant, spc title, spc number, spc country, patent number for spc, original expiry date, spc status, patent title, national first authnumber, national first authorization date, *     international non-propoiertary name (INN), patentnumber (among other variables)*speciality: first market authorization date, country, product name, international non-propoiertary name (INN) *document: chemicalname, tradenames, chemicalname, dosageforms, chemical category, biological category (among other variables) *dosage: product, market authorization country, tradename, prescription status, market authorization holder, dosage form, strength, inn (among other variables) *Unit of observation differs across the five tables (see do dofile5_patent_spc_merge_tables)/**Data are proprietary and confidential. For data inquiries, please contact:INSIGHT Health GmbH & Co. KGAuf der Lind 1065529 Waldems-EschTel.: 06126/955-0Fax: 06126/955-20E-Mail: info@insight-health.dehttp://www.insight-health.de/ */*** (I) DATA MATCHING *Matching of NPI data tables (separately for each database: NPI DB05, DB06, DB07)do dofile1_npi_merge_tables_db05do dofile2_npi_merge_tables_db06do dofile3_npi_merge_tables_db07*Matching of NPI data (as extracted from NPI NPI DB05, DB06, DB07) and data cleaning do dofile4_npi_merge_db*Matching of patent and supplementary protection certificate (SPC) data do dofile5_patent_spc_merge_tables*** (II) DATA PREPARATION*Data confined to human medicines and matched to patent/spc data, incl.:*renaming of variables (variable names translated from German to English) and generation of new variables, e.g. id for active generic drug manufacturers, see dofile] do dofile6_npi_human1_2*Patent expiries and generic entry (79 drug markets) [generation of new variables, e.g. id for substances with patent/spc expiry, generic entrants and originators, see dofile] ]do dofile7_npi_human3_4*Generate two sets of potential generic entrants (75 drug markets: no lung, eye or systemic use) *Copmute theraputic and drug form experience of potential and actual generic entrantsdo dofile8_npi_human4_potentrants*Final data sets for regression analysis (two sets of potential entrants: 73 drug markets with a positive number of potential and/or actual generic entrants)do dofile9_npi_human5_final*** (III) ECONOMETRIC ANALYSIS OF THE IMPACT OF AITHORIZED GENERIC ENTRY ON INDEPENDENT GENERIC ENTRY DECISIONS  *Summary statistics, probit and recursive bivariate probit regression and 2SLS estimation do dofile10_npi_human5_final_analysis*DATA DICTIONARY:*Unit of observation: generic entry decision (drug x potential/actual generic entrant) *Data set 1: 7315 observations (73 drug markets); data set 2: 2009 observations (73 drug markets)*Defintion of variables:*Generic entry: 0-1 dummy variable,=1 if an independent generic firm decided to enter a drug market following loss of exclusivity (LoE) patent or SPC expiry.*Authorized generic entry 0-1 dummy variable,=1 if the originator authorized generic entry prior to LoE through an agreement with a generic division or licensee.*Pre-entry revenues: log of annual drug market revenues (in EUR million) two calendar years prior to LoE.*Monopoly Duration: number of years from brand drug's market launch to LoE.*Substitutes (B): number of on-patent prescription drugs which are listed in the same therapeutic field(s) of indication (ATC3 classification) as the reference drug at the time of LoE.*Substitutes (G): number of off-patent prescription drugs, available in generic form, that are listed in the same therapeutic field(s) of indication (ATC3 classifiation) as the reference drug at the time of LoE.*Field experience: number of potential/generic entrants's product launches in applicable therapeutic fields of indication (ATC3 classification) prior to LoE.*Form experience: number of potential/generic entrants's product launches with identical route of administration (NFC3 classfication) prior to LoE.*Share of non-core products: share (%) of non-core (non-human medicines), non-generic products (e.g. diganostics) introduced by the originator within one year prior to LoE relative to originator's drug pipeline one year prior to LoE.*Therapeutic field: 0-1 dummy variable,=1 if the drug is applicable in a specific therapeutic fields of indication prior to LoE (13 ATC1 classes).*Drug rorm: 0-1 dummy variable,=1 if the drug is primarily administered orally, parenterally, or topically prior to LoE.*2002 / 2003 / 2004 / 2005 / 2006 / 2007: 0-1 dummy variable,=1 if LoE occurs in calendar year 2002, 2003, 2004, 2005, 2006, 2007.*Small/ Medium/ Large: 0-1 dummy variable,=1 if the drug market is small, medium or large (see do dofile7_npi_human3_4).*Rx-to-OTC: 0-1 dummy variable,=1 if an rx-to-otc (prescription to over the counter) switch of the drug in reference occured prior to LoE.*SGP: 0-1 dummy variable,=1 if a second generation product was issued prior LoE.*Litigation: 0-1 dummy variable,=1 if patent litigation occured prior to LoE.*** end of do file